ZetrOZ's Ultrasonic Diathermy device is intended for use as a portable and wearable medical device which, when applied to various areas of the body applies Low Intensity Therapeutic Ultrasound (LITUS) to deep tissues. This device is FDA-cleared for pain reduction, treatment of muscle spasm and joint contracture, and increasing local circulation. This study will look at the use of therapeutic ultrasound to relieve pain and reduce disability in subjects with chronic low back pain, a subset of which will have chronic low back pain due to a herniated disc, over an 8-week treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
65
Long-duration, low-intensity therapeutic ultrasound device that is self-applied and wearable, delivering treatment up to 4 hours per day.
Inactive ultrasound device
Medical Pain Consultants
Dryden, New York, United States
Osteopathic Medical Arts
Chapel Hill, North Carolina, United States
Weber State University
Ogden, Utah, United States
Brief Pain Inventory-Short Form (BPI-SF): Pain Severity
Time frame: Change from Baseline to Week 8
BPI-SF: Pain Interference
Time frame: Change from Baseline to Week 8
Oswestry Disability Index
Time frame: Change from Baseline to Week 8
Numeric Rating Scale: Pain on Flexion
Time frame: Change from Baseline to Week 8
Numeric Rating Scale: Pain on Extension
Time frame: Change from Baseline to Week 8
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